FDA Related News

Human Drugs

FDA Generic Drug Activities Reports

FDA releases statistics for the first two quarters of FY 2021 on actions relating to section 505(j) ANDAs.

Human Drugs

Emergent Bio Covid Vaccine 9-Item FDA Form-483

FDA releases a nine-item Form-483 less than 24 hours after it completed an inspection of Emergent BioSolutions Baltimore manufacturing plant that show...

Medical Devices

FDA Approves Medtronic Pipeline Device

FDA has approved the Medtronic Pipeline Flex embolization device with the companys proprietary Shield Technology.

Biologics

FDA Denies Cell2in Cell-Based Therapy Petition

FDA denies a Cell2in petition seeking inclusion of GSH monitoring in certain guidances as a means to measure the potency of cellular therapy products.

Medical Devices

LivaNova Blood-Gas Monitor for Heart-lung Machine

FDA clears a LivaNova 510(k) for B-Capta, an in-line, blood-gas monitoring system integrated into its S5 heart-lung machine.

Medical Devices

J&J Cataract Surgical Device Cleared

FDA clears a Johnson & Johnson Vision 510(k) for its Veritas Vision System, a phacoemulsification (cataract surgery) device that allows surgeons to gu...

FDA Should Disclose Confidential Drug, Vaccine Data: Article

Two Yale Law School professors suggest changes to FDA to create a clinical trial publicity regime exposing confidential data.

Biologics

FDA HCT/P Enforcement Discretion Ending 5/31: Marks

CBER director Peter Marks says enforcement discretion for IND and premarket application requirements for certain regenerative medicine products will n...

Human Drugs

ICH Publishes E6 Good Clinical Practice Draft

The International Council for Harmonization publishes a draft version of its E6 good clinical practice guideline.

Biologics

EMA Adds Warning to J&J Vaccine; Supports Use

A European Medicines Agency safety review says Johnson & Johnsons Covid-19 vaccine continues to have a favorable benefit-risk profile but it should ca...